Medical & Scientific Writing
We author and contribute to clinical, regulatory, and scientific documents for medicines and medical devices. From protocols and Investigator's Brochures through CTD Modules, CERs, ODDs and PIPs to authority response packages, we produce submission-ready content from your source data, and do not just review existing drafts. Our writing team combines hands-on clinical development experience with regulatory and scientific writing expertise, to make sure the documents reflect the underlying strategy, not just the data.
Examples of How We Support
These are just a few examples to illustrate the kind of work we commonly support.
Clinical writing bandwidth
Your clinical program is moving fast and your team does not have the writing bandwidth. Synopses, protocols, and Investigator's Brochures need to be regulator-ready, consistent, and delivered following a strict timeline.
MAA clinical documentation
You are preparing a marketing authorisation application and need the clinical story to hold together. CTD Modules 2.5, 2.7, Module 5, SmPC, and RMP need to be compiled from multiple data sources into a coherent package.
CER or PER update
Your CER or performance evaluation report needs an update that will stand up under MDR or IVDR review. Systematic literature searches, PMS data, and clinical evidence need to be integrated into a document that satisfies notified body expectations.
Authority response writing
You've received assessment questions from an authority or notified body. You need structured response documents and updated sections across the file, turned around within a tight deadline.
Due diligence gap assessment
You're evaluating an asset for in-licensing or due diligence and need a gap assessment of the existing clinical and scientific documentation, with a clear view of what's missing and what it will take to close.
Understanding Medical & Scientific Writing
“Medical writing” and “scientific writing” are used loosely in the industry. Medical writing usually refers to regulated clinical and regulatory documentation (protocols, CTD modules, clinical evaluation reports, ODDs, PIPs). Scientific writing often refers to publications and scientific communications (manuscripts, posters, abstracts).
We cover both. This page addresses all document types that support regulatory submissions, ethics committee filings, and post-market obligations, as well as publication outputs aligned with the underlying evidence.
What We Do
We author, compile, and finalise documents across the full development lifecycle for both pharma and device programs:
Our Workstreams
Writing is part of almost every development activity. To make the scope clear, we structure our support by document domain.
Clinical Trial Documentation
Synopses and protocols, Investigator's Brochures, clinical study reports, and updates of ethics and authority submission packages.
Regulatory Clinical Package (CTD)
Modules 2.5 and 2.7, Module 5, RMP strategy/compilation, narrative consistency across the clinical files.
Medical Device Clinical & Post-Market Documentation
CER/PER aligned with MEDDEV 2.7/1 rev.4 and current MDCG guidance (including MDCG 2020-5 on equivalence, MDCG 2020-6 on legacy devices), SSCP/SSP per MDCG 2019-9, PMS plans, PSURs, and PMCF/PMPF documentation under MDR/IVDR.
Scientific and Regulatory Justifications
PK-based argumentation, Biowaiver and reclassification rationales, position papers, structured literature reviews and gap assessments.
Publications and Scientific Communications
Manuscripts, abstracts, posters and scientific articles, aligned with source data and author review.
Where This Fits in the Development Journey
Writing outputs change as a program moves through development. This overview shows where medical and scientific writing typically contributes at each stage.
Discovery & Concept
Development planning support through structured literature research and feasibility assessments that inform early decisions and the Target Product Profile.
Preclinical
Draft early clinical and scientific strategies for FIH planning, such as selection of starting dose and PD/Biomarker monitoring to allow drafting of initial Investigator's Brochure content and key justifications.
Design & Development
Work with regulatory leads to prepare materials that shape the development strategy, including gap analysis, outline the clinical development plan, scientific advice briefing books and supporting documents.
Clinical
Synopses, protocols, Investigator's Brochure authoring and maintenance, clinical study reports, and Scientific Advice Briefing Books.
Regulatory Submission & Approval
CTD clinical content (Modules 2.5/2.7, Module 5 and RMP) and structured responses to authority assessment questions and clock-stops.
Launch & Market Access
Product-facing clinical/scientific texts where needed (e.g., SmPC/PIL or equivalent), aligned with the dossier and labelling discussions.
Post-Market & Lifecycle Management
Maintenance and updates of clinical/performance and post-market documentation where applicable (e.g., CER/PER, SSCP/SSP, PMS, PSUR, PMCF/PMPF), and response packages for notified body/authority questions.
Product Type Considerations
The type of product shapes both the document set and the regulatory expectations our writers work to.
Biologics & ATMPs
CTD structure, greater emphasis on mechanism-of-action narratives, comparability arguments, and complex risk discussions (e.g. immunogenicity).
Medical Devices & IVDs
CER/PER under MDR/IVDR, SSCP/SSP, PMS/PMCF documentation. Writing must align with MEDDEV 2.7/1 rev.4, MDR/IVDR, and notified body expectations. Increasing emphasis on integration of real-world data and post-market surveillance findings into clinical evaluations.
Combination Products
Integration of device usability, human factors, and device-specific risk analyses into CTD and clinical evaluation reports. Article 117 documentation requirements.
Small Molecules
CTD structure, but often requires specific justification work (PK argumentation, biowaivers, reclassification rationales).
Digital Health & SaMD
Documentation must address SaMD classification, MDR/IVDR alignment and EU AI Act expectations.
Example Projects
Illustrative Example
EU Pharma: CTD Clinical Modules for a Marketing Authorisation Application
A European pharmaceutical company was preparing an MAA for a small molecule and needed CTD Modules 2.5, 2.7, and Module 5 authored from multiple clinical study reports and nonclinical data. We wrote the Clinical Overview and Clinical Summary, compiled and quality-checked the CSRs, ensured narrative consistency across all clinical modules, and prepared structured responses to the day-120 assessment questions. The application received a positive opinion without a second assessment round on clinical.
Illustrative Example
Medical Device Company: CER Update for a Class IIb Active Device Under MDR
A device manufacturer needed to update the clinical evaluation report for a Class IIb active device ahead of a Notified Body audit. The existing CER had been authored under MEDDEV 2.7/1 rev.3 and did not meet current expectations. We conducted a new systematic literature search, integrated post-market surveillance data, rewrote the equivalence argumentation in line with MDCG 2020-5, and produced a CER aligned with MEDDEV 2.7/1 rev.4 and MDCG guidance. The Notified Body accepted the updated CER without major findings.
Illustrative Example
Biotech: IB and Protocol Authoring for a Phase I/II Oncology Trial
A biotech entering clinical development for a first-in-class oncology compound needed an Investigator's Brochure and Phase I/II protocol authored from existing nonclinical and early CMC data. We wrote the IB from source, including a structured nonclinical summary, clinical implications section, and safety monitoring guidance. We then authored the protocol incorporating ICH E6(R3) quality-by-design principles and risk-based monitoring elements. Both documents were accepted by the ethics committee and authority without requests for major revision.
Need Writing Support for a Submission, a Clinical Program, or a Post-Market Update?
Tell us about your product and timeline, and we’ll outline how we can help.
Speak with an ExpertFrequently Asked Questions (FAQ)
When should we involve medical writers?
As early as possible. Our senior writers bring more than 20 years of clinical development experience each, which means they can contribute to shaping the evidence strategy from the very start. If you have a Target Product Profile, you have enough to start structuring your evidence narrative and aligning early documents (IBs, protocols, Briefing Documents) with the regulatory pathway. Early involvement prevents rework when the submission deadline arrives.
Do you write documents from scratch, or only review drafts?
Both, but we are strongest when writing from source data and materials. We take clinical data, study reports, literature search outputs, and regulatory inputs and turn them into submission-ready documents. We also review and restructure existing drafts where that is what's needed.
Do you handle both authoring and submission?
Yes. We write, review, and finalise CTD modules, CERs, PSURs, ODDs, PIPs and other documents, and coordinate with the regulatory team to publish and submit them. We also prepare response packages for authority and notified body questions.
Can you adapt documents for multiple regions?
We create core documents that satisfy both EMA and FDA structures, then adjust formatting and emphasis for regional expectations (e.g. EMA Scientific Advice vs. FDA type A, B, C, and D meetings Briefing Documents). For markets beyond the EU and US, we coordinate with local regulatory experts through regulanet®, our global network, to ensure documents meet local authority requirements while keeping the core content consistent.
What if our trial data or literature search reveals gaps?
We flag gaps early and propose next steps: supplementary studies, bridging justifications, strengthened post-market plans, or revised evidence strategies. We don't just document the gap; the goal is we help you close it.
How does your writing team work with our internal reviewers?
We follow a structured review cycle: first draft, consolidated comments, revision, final QC. We manage the document through each round and track all changes. For large submissions, we coordinate review across multiple internal and external contributors to keep the timeline on track.
Do you prepare Summary of Safety and Clinical Performance (SSCP) documents?
Yes. We author SSCPs for implantable and Class III devices under MDR, and SSPs (Summary of Safety and Performance) for certain IVDs under IVDR, aligned with MDCG 2019-9 guidance. These documents are intended for patients and healthcare professionals and must be written in clear, non-promotional language while accurately reflecting the clinical evidence and risk profile. We prepare them as part of the clinical documentation package and coordinate the manufacturer validation process before upload to EUDAMED.
Can you handle response packages for Notified Body questions?
Yes. Notified Body review cycles for CERs, PERs, and technical documentation generate detailed questions that require structured, evidence-based responses. We prepare the response documents, update the affected sections of the clinical evaluation or technical file, and ensure consistency across the documentation. The process is analogous to responding to health authority assessment questions for pharmaceutical submissions, but the document set and review expectations are different.